Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery: Rationale and design of the multicenter, randomized PROCTOR trial.

BACKGROUND: Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. METHODS: PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). CONCLUSION: PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.

Intrinsic network interactions explain individual differences in mentalizing ability in adolescents.

Mentalizing is an important aspect of social cognition and people vary in their ability to mentalize. Despite initial evidence that mentalizing continues to develop throughout adolescence, it is unclear which neural mechanisms underlie individual variability in mentalizing ability in adolescents. Interactions within and between the default-mode network (DMN), frontoparietal network (FPN) and cingulo-opercular/salience network (CO/SN) have been related to inter-individual differences in cognitive processes in both adults and adolescents. Here, we investigated whether intrinsic connectivity within and between these brain networks explained inter-individual differences in affective mentalizing ability in adolescents. Resting-state brain activity was measured using functional MRI and affective mentalizing ability was defined as correct performance on the Reading the Mind in the Eyes test performed outside the scanner. We identified the DMN, FPN and CO/SN, and within and between network connectivity values were submitted to a bootstrapping enhanced penalized multiple regression analysis to predict mentalizing in 66 young adolescents (11-14 years). We showed that stronger connectivity between the DMN and the FPN, together with lower within-network connectivity of the FPN and the CO/SN predicted better mentalizing performance. These novel findings provide insight into the normative developmental trajectory of the neural mechanisms underlying affective mentalizing in early adolescence.